Letrozole + Everolimus + TRC105 for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of three drugs—Letrozole, Everolimus, and TRC105—to evaluate their effectiveness in treating certain types of breast cancer before surgery. Letrozole and Everolimus block signals that promote cancer growth, while TRC105 aims to cut off the blood supply to the cancer. The goal is to determine if this drug combination is safe and effective for individuals with Stage 2 or 3 hormone receptor-positive, HER2-negative breast cancer. Those newly diagnosed with this type of breast cancer, who are postmenopausal and have not received prior treatment, may be suitable candidates for this study. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of Letrozole, Everolimus, and TRC105 can cause some common side effects. Participants often experienced headaches, tiredness, facial redness, and swelling. Other reported issues included bleeding gums and nosebleeds. These side effects were common but varied in severity among individuals.
This trial is in its early stages, focusing mainly on safety and tolerability. These early phases are crucial for understanding the body's response to the combination. Letrozole and Everolimus are already approved for other uses, indicating a known safety profile. However, TRC105 remains under study, so its safety is less certain.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Letrozole, Everolimus, and TRC105 for breast cancer because it targets the disease in a unique way. Unlike standard treatments that often focus on hormone suppression or chemotherapy alone, this combination therapy adds an anti-angiogenic agent, TRC105, which works by inhibiting blood vessel growth that tumors need to thrive. Everolimus, an mTOR inhibitor, further disrupts cancer cell growth and survival pathways, while Letrozole continues to suppress estrogen production. This multi-faceted approach is promising because it simultaneously attacks cancer cells on multiple fronts, potentially leading to more effective outcomes and improved patient responses compared to existing treatments.
What evidence suggests that this trial's treatments could be effective for breast cancer?
Research has shown that combining everolimus with letrozole can prolong the period before cancer worsens. Everolimus has proven especially effective in certain types of breast cancer, particularly when the cancer has returned or spread. Letrozole blocks estrogen, a hormone that some breast cancers require for growth. TRC105, the investigational drug in this trial, inhibits blood vessels that support tumor growth. This trial will explore the combination of everolimus, letrozole, and TRC105, which findings suggest could be promising for treating breast cancer before surgery.15678
Who Is on the Research Team?
Erica Stringer-Reasor, M.D.
Principal Investigator
University of Alabama at Birmingham
Erica Stringer-Reasor, MD
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
This trial is for postmenopausal women with Stage 2 or 3 hormone receptor-positive and HER2-negative breast cancer, who haven't had treatment for it yet. They should be relatively healthy (ECOG < 2), have good blood counts and liver/renal function, and must consent to the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Determine the ideal combination of doses of Letrozole, Everolimus, and TRC105 for tolerance
Phase II Treatment
Participants receive the investigational combination of Letrozole, Everolimus, and TRC105 to assess preliminary efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Everolimus
- Letrozole
- TRC105
Everolimus is already approved in United States, European Union for the following indications:
- Advanced renal cell carcinoma
- Subependymal giant cell astrocytoma
- Progressive neuroendocrine tumors of pancreatic origin
- Advanced hormone receptor-positive, HER2-negative breast cancer
- Tuberous sclerosis complex-associated partial-onset seizures
- Subependymal giant cell astrocytoma
- Renal angiomyolipoma
- Tuberous sclerosis complex-associated partial-onset seizures
- Prevention of organ rejection in kidney transplant patients
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
Tracon Pharmaceuticals Inc.
Industry Sponsor
Novartis Pharmaceuticals
Industry Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD